S'INSCRIRE

Offres d'emploi

Trouvez des postes près de chez vous, sur site, hybrides ou à distance.
  • Emplois similaires à : Quality Lead
XX
Quality Assurance LeadDM Clinical Research • Houston, Texas, United States
Postuler Maintenant
XX

Quality Assurance Lead

DM Clinical Research
  • US
    Houston, Texas, United States
  • US
    Houston, Texas, United States
Postuler Maintenant

À propos

The Quality Assurance Lead oversees quality assurance functions for the organization including, but not limited to development and maintenance of quality assurance programs and policies, oversight of inspections and audits, and management of Quality Documents. Ensure productivity per the company's goals.
DUTIES & RESPONSIBILITIES
Maintaining a working knowledge of current FDA regulations, GCP/ICH guidelines, organizational SOPs, guidance documents, and study protocols.
Developing, implementing, and maintaining an internal audit monitoring system and schedule.
Leading the ongoing development, management, and implementation of written processes for effectively managing clinical trials.
Leading the reporting of trends and metrics from all clinical activities to aid in effective process improvement and risk control.
Maintaining Standard Operating Procedures (SOPs) including periodic review and coordination of the initiation/revision of procedures and policies to ensure compliance with new/revised regulations and guidelines
Ensuring quality incidents are investigated, root cause analysis is performed, and CAPA has been implemented and monitored for effectiveness.
Performing Quality Documents review and approval (e.g. SOPs, guidance documents)
Partnering with study teams to identify potential changes and opportunities for process improvement
Educating and mentoring the research team with the interpretation of regulatory requirements (e.g., GCPs), SOP requirements, and other guidance documents, as applicable.
Evaluating responses to monitoring and audit reports with the research team; follow-up with applicable stakeholders to ensure resolution.
Functions within study teams to conduct feasibility assessments, and ongoing quality assurance reviews of clinical research studies, with the goal of assessing site readiness and developing site-specific education and processes as needed.
Report quality assurance trends/metrics to Sr. Management.
Any other matters as assigned by management.
KNOWLEDGE & EXPERIENCE Education Experience
3 years of clinical research experience
1-2 years experience as QA Associate
Credentials
Related certifications (CCRP, CCRA, CCRC, or similar) preferred
Knowledge and Skills
Effective organization, communication, and leadership skills
Effective working relationships with coworkers, managers, and external clients
Strong ability to lead and manage multiple responsibilities
Ability to articulate and define departmental needs and processes
#J-18808-Ljbffr
  • Houston, Texas, United States

Compétences linguistiques

  • English
Avis aux utilisateurs

Cette offre provient d’une plateforme partenaire de TieTalent. Cliquez sur « Postuler maintenant » pour soumettre votre candidature directement sur leur site.

10'000+ emplois près de chez vous | TieTalent